HbA1c <7.0% [ Time Frame: 13 weeks ]
Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
HbA1c <7.0% in participants with baseline HbA1c >7.5% [ Time Frame: 13 weeks ]
Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups
HbA1c <7.5% [ Time Frame: 13 weeks ]
Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups
HbA1c improvement from baseline to 13 weeks >0.5% [ Time Frame: 13 weeks ]
Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups
HbA1c improvement from baseline to 13 weeks >1.0% [ Time Frame: 13 weeks ]
Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups
HbA1c relative improvement from baseline to 13 weeks >10% [ Time Frame: 13 weeks ]
Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups
HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks [ Time Frame: 13 weeks ]
Number of participants with HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
Time in range 70-140 mg/dL [ Time Frame: 13 weeks ]
Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups
Area over the curve (70 mg/dL) [ Time Frame: 13 weeks ]
CGM area over the curve (70 mg/dL), compared between the intervention and control groups
Low blood glucose index [ Time Frame: 13 weeks ]
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia, compared between the intervention and control groups. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.
Time >300 mg/dL [ Time Frame: 13 weeks ]
Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups
Area under the curve (180 mg/dL) [ Time Frame: 13 weeks ]
CGM area under the curve (180 mg/dL), compared between the intervention and control groups
High blood glucose index [ Time Frame: 13 weeks ]
High Blood Glucose Index (HBGI) by CGM, compared between the intervention and control groups., as a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia.
Time in range 70-180 mg/dL >70% [ Time Frame: 13 weeks ]
Number of participants with time in range 70-180 mg/dL >70%, compared between the intervention and control groups
Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5% [ Time Frame: 13 weeks ]
Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%, compared between the intervention and control groups
Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10% [ Time Frame: 13 weeks ]
Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%, compared between the intervention and control groups
Time <70 mg/dL <4% [ Time Frame: 13 weeks ]
Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups
Time <54 mg/dL <1% [ Time Frame: 13 weeks ]
Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups
Time in range 70-180 mg/dL >70% and time <54 mg/dL <1% [ Time Frame: 13 weeks ]
Number of participants with time in range 70-180 mg/dL >70% and time <54 mg/dL <1%, compared between the intervention and control groups
Total Insulin [ Time Frame: 13 weeks ]
Total daily insulin delivery (units), compared between the intervention and control groups
Basal insulin [ Time Frame: 13 weeks ]
Percentage of insulin delivered as basal, compared between the intervention and control groups
Weight [ Time Frame: 13 weeks ]
Change in weight (kg) from baseline, compared between the intervention and control groups
Blood Pressure [ Time Frame: 13 weeks ]
Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
Lipid levels [ Time Frame: 13 weeks ]
Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
Cardiovascular events [ Time Frame: 13 weeks ]
Number of cardiovascular events, compared between the intervention and control groups
Type 2 Diabetes Distress Assessment System (T2-DDAS Combined – Core and Source) [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from Type 2 Diabetes Distress Assessment System (T2-DDAS Combined – Core and Source) questionnaire, compared between the intervention and control groups
DAWN Impact of Diabetes Profile (DIDP) [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups
Diabetes Impact and Satisfaction (DIDS) Scale [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups
PROMIS Sleep-Related Impairment Questionnaire [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups
System Usability Scale (SUS) [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups
Hypoglycemia Fear Survey II [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II, compared between the intervention and control groups
EQ5D-5L [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups
Study-specific survey [ Time Frame: 13 weeks ]
Patient-reported outcome (PRO) measures from study-specific survey exploring time spent on insulin management and insulin dosing with meals, compared between the intervention and control groups
Hypoglycemia Frequency Last 3 Months Survey [ Time Frame: 13 weeks ]
Number of non-severe hypoglycemic events reported, compared between the intervention and control groups from baseline report to 13 weeks.
Severe hypoglycemia [ Time Frame: 13 weeks ]
Number of Severe hypoglycemia events, compared between the intervention and control groups
Diabetic ketoacidosis [ Time Frame: 13 weeks ]
Number of Diabetic ketoacidosis events, compared between the intervention and control groups
Hyperosmolar hyperglycemic syndrome [ Time Frame: 13 weeks ]
Number of Hyperosmolar hyperglycemic syndrome events, compared between the intervention and control groups
Other serious adverse events [ Time Frame: 13 weeks ]
Number of other serious adverse events
Unanticipated adverse device effects [ Time Frame: 13 weeks ]
Number of Unanticipated adverse device effects
Infusion set failures [ Time Frame: 13 weeks ]
Number of infusion set failures
Other device malfunctions/device issues [ Time Frame: 13 weeks ]
Number of other device malfunctions/device issues
Source: View full study details on ClinicalTrials.gov
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